NCT03350230

Brief Summary

looking at aneuploidy rates in embryos from patients who are going to or have undergone treatment for a malignancy with gonadotoxic treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

November 13, 2017

Last Update Submit

May 2, 2023

Conditions

OncologyFertility

Outcome Measures

Primary Outcomes (1)

  • embryonic aneuploidy rates

    to evaluate the incidence of embryonic aneuploidy among oncofertility patients compared to the general infertility population

    1 month

Study Arms (1)

oncofertility patients

oncofertility patients undering controlled ovarian hyperstimulation and embryo cryopreservation who carry a present or past cancer diagnosis

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

oncofertility patient undergoing controlled ovarian hyperstimulation and embryo cryopreservation

You may qualify if:

  • Present or past oncologic diagnosis requiring potentially gonadotoxic treatment

You may not qualify if:

  • Oocyte banking
  • Use of oocyte donation
  • Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
  • Single gene disorder requiring more detailed embryo genetic analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood specimens and buccal swabs

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Jason Franasiak, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 22, 2017

Study Start

December 1, 2017

Primary Completion

March 27, 2020

Study Completion

July 21, 2022

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)